Neodent 140.898Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07899878018087), received between Nov 14, 2017 and Nov 13, 2018 — classified as 8 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT 5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 4 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS. (B)(4).

  Patient problems: Failure of Implant; Tissue Damage

  MAUDE report 8065251 ↗
• InjuryOct 26, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT OVER 4 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 4 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: Failure of Implant; Tissue Damage

  MAUDE report 8010408 ↗
• InjuryJun 28, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT FOUR MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 13 IN THE MOUTH, THE IMPLANT HAD NOT ACHIEVED OSSEOINTEGRATION IN TYPE I BONE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7647684 ↗
• InjuryFeb 23, 2018Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  THE CLINICIAN REPORTS MORE THAN 6 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 4 IN TYPE III BONE, THE IMPLANT HAD LOST OSSEOINTEGRATION. THE SITE WAS NOT GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7293543 ↗
• InjuryFeb 13, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THAT 5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 15 IN TYPE I BONE, THE IMPLANT HAD NOT YET ACHIEVED OSSEOINTEGRATION. A BONE GRAFT WAS PLACED. CLINICIAN REPORTS DISCOMFORT WHICH WENT AWAY AFTER THE IMPLANT'S REMOVAL. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7268215 ↗
• InjuryFeb 7, 2018Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  THE CLINICIAN REPORTED THAT 16 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 4, THE IMPLANT LOST OSSEOINTEGRATION. CLINICIAN REPORTS MOBILITY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7249341 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER THE IMMEDIATE EXTRACTION OF THE TOOTH IN ADA SITE 19, THE CLINICIAN REPORTS THE IMPLANT FAILED UPON INSERTION DUE TO INADEQUATE TORQUE. THE IMPLANT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7162158 ↗
• InjuryNov 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICIAN REPORTED THAT ON THE DATE OF PLACEMENT IN ADA SITE 25, A FAILURE OCCURRED UPON INSERTION. PRIMARY STABILITY WAS NOT OBTAINED. PATIENT PRESENTED WITH TYPE II BONE. INSUFFICIENT BONE QUALITY WAS NOTED AND A BONE GRAFT WAS PLACED. THE IMPLANT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT INJURIES OR POST-OPERATIVE COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7030118 ↗